BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMNISURE

    MDR report key: 3844613 · Received May 28, 2014

    Report

    Report Number
    3005345832-2014-00001
    Event Type
    Death
    Date Received
    May 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AMNISURE INTERNATIONAL, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT THE RESULT OBTAINED FROM THE DEVICE DID NOT CONTRIBUTE OR CAUSE THE DEATH OF THE FETUS. HOWEVER, INFORMATIONAL PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFO, AS NECESSARY. BASED ON THE INFORMATION PROVIDED, IT IS CLEAR THAT THE TEST WAS NOT PERFORMED ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE. THE HEALTHCARE FACILITY REPORTED UNEXPECTED NEGATIVE RESULTS ALTHOUGH THERE WAS EXCESSIVE BLOOD PRESENT IN THE THREE PT SAMPLES. THE PT ALSO PRESENTED WITH OTHER COMPLICATIONS. THE TEST DID PERFORM AS EXPECTED WHEN A 4TH SAMPLE TESTED WITH SIGNIFICANTLY LESS BLOOD PRESENT THAN THE FIRST THREE AND AN ACCUMULATION OF AMNIOTIC FLUID. IN GENERAL, THE PRODUCT INSTRUCTION FOR USE ADVISED PHYSICIANS TO EVALUATE ALL RESULTS IN CONJUNCTION WITH ADDITIONAL CLINICAL INFO.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED (B)(6) 2015 REGARDING A PT WHO WAS AT 22 WEEKS GESTATION, PRESENTED WITH BLEEDING, INFECTION, CRAMPING, LOW AMNIOTIC FLUID AND ROM. FOUR (4) AMNISURE (AS) TESTS WERE ADMINISTERED AS WELL AS ONE (1) FERN. THE FIRST THREE (3) AS TESTS AND THE ONE (1) FERN TEST WERE ALL NEGATIVE. THE FOURTH (4TH) AS TEST WAS POSITIVE AFTER POOLING OF AMNIOTIC FLUID TAKEN FROM PT WITH DECREASED AMOUNTS OF FLOOD IN THE SAMPLE. PT DELIVERED RESULTING IN A FETAL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314536 AMNISURE RAPID RETAL MEMBRANCE RUPTURE TEST NQM AMNISURE INTERNATIONAL, LLC FMRT-1 A1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Death